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05

Jan

2012

Research and Clinical Development Industries in the US Must Start to Extend Beyond the US

If research and development in medicine is to move at anywhere near the pace it is capable of, given the rapid progress in all forms of underlying biotechnology, it must find a way to extend beyond the most heavily regulated regions. The most capable and largest research communities, like that based in the US, are also those with the least ability to locally develop their advances into medical products, thanks to the straitjacket of regulation from government bodies like the FDA.

For much of clinical development, this means that the expense imposed by the FDA makes progress either very slow indeed - and lacking in the competitive vigor that characterizes less regulated industries - or simply non-existent where the costs make a business of medicine unprofitable. Much of this weighing down of development is invisible to the casual observer: you cannot see lost opportunities, or count the medical technologies that might already exist if not for decades of the ball and chain of the FDA.

For some potential clinical applications it's worse than that: they are simply forbidden outright, with no path towards becoming permitted. Treatment of aging, development of rejuvenation biotechnology, is one such field in the US. The FDA doesn't recognize aging as a medical condition, and so will not approve treatments aimed to intervene in aging. Given that, raising funds for development of potential longevity science is very hard - there is next to no for-profit funding, and where that funding does exist, the regulatory path to approval steers development away from potentially useful treatments for aging into the sidelines of diabetes therapy or late-stage treatment of other age-related conditions. This effectively prevents any effective path towards longevity-enhancing therapies for healthy people from being followed within the US.

The way out of this mess, short of a revolution or collapse of government, is a systemic extension of the industry of clinical application of longevity science to include regions outside the US. The logical end result of the growing medical tourism industry is better defined roadway of connections and multinational organizations that will usher scientific developments from regions like the US into other parts of the world where they can be offered as clinical treatments. What has happened for stem cell therapies and medical tourism in the past decade is just a tiny beginning, a few first steps towards what must become a much more systematic, high-bandwidth, highly visible, reliable transfer of knowledge and funds - such that the US government can't just shut it down with a few threats of prosecution, such that every life scientist in the US knows how to monetize their research outside the US by shopping around for deals with offshore developers, and such that a large enough and competitive enough marketplace exists to make that shopping around a viable process.

What is the likelihood of seeing research vessels devoted to scientific research outside the bounds of national jurisdiction? The idea of relocating for the sake of circumventing law, in particular the notion of establishing new nations in international waters, is an idea typically initiated with liberty in mind. ... For instance, the idea of ships offering in vitro fertilization, flying Denmark flags, has been proposed to provide UK residents with a service, locally illegal. In the U.S., major delays in safe and effective regenerative medical services are likely. Regenerex, a company offering regenerative stem cell therapies, faces a potential halt in operation by the FDA. The company has been in dispute with the FDA over whether or not stem cell therapies should be considered 'drug' therapies. If the FDA succeeds in this dispute, Regenerex would then be required, by law, to discontinue treatments until appropriate certification is in place, which could be 'staggeringly expensive' and take several years.

Biotech companies researching longevity also inconveniently face roadblocks from the FDA, which only approves drugs aimed at treating diseases in a specific, defined manner. Aging is not currently considered a disease by the FDA, which makes the delay of essential treatment virtually inevitable. The need for extensive reform in policy is a reality of a good deal of near and future medical services, and both businesses and patrons are incentivized by the unique opportunity of circumventing regulatory systems.

I don't think that the sea is the answer on the scale of development industry needed to break loose the FDA's ball and chain - the goal seems to me to more a case of linking existing (land-based) infrastructure and development institutions, creating the roadway of knowledge, deals, and contractual ties, and the community that sustains that roadway.

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